9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TIBIAL NAIL, STANDARD 10X390 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·March 17, 2010
Ilumien Optis, Optis Integrated, Optis Mobile
FDA 510(k)
FDA Class 2
·Radiology
DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 7, 2013
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·July 2, 2014
TEMP PUMP
FDA Adverse Event
Malfunction
·GAYMAR INDUSTRIES, INC.·Product code ILO·February 4, 2011
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·October 30, 2024
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·October 30, 2024